A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Topical ESR-114 in Subjects With Plaque Psoriasis

NCT03630939 | Completed Phase 1 FDA Drug

• 1 other identifier: ESR-114-101
• Study Type: interventional
• Target: 104
• Locations: 2 countries
• Sites: 10

Brief Summary

This is a multicenter, double-blind, randomized, vehicle-controlled, parallel-group proof-of-concept study designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of topically applied ESR-114 following twice daily (BID) application for 42 days (6 weeks).

Conditions

Psoriatic Plaque

Outcome Measures

Primary Outcomes (1)

• Change in Total Lesion Severity Score

  Change from Baseline in Total Lesion Severity Score (sum of scores for Induration, Erythema, \& Desquamation; score range: 0-12; lower score is better outcome) at Week 6

  6 weeks

Secondary Outcomes (5)

• Proportion of subjects with clear or almost clear on the Physician Global Assessment

  6 weeks

• Proportion of subjects with PASI75

  6 weeks

• Change from Baseline in erythema score over time

  6 weeks

• Change from Baseline in induration score over time

  6 weeks

• Change from Baseline in desquamation score over time

  6 weeks

Study Arms (3)

ESR-114 1.5%

EXPERIMENTAL

ESR-114 1.5% Topical Gel BID for 6 weeks

Drug: ESR-114

ESR-114 5.0%

EXPERIMENTAL

ESR-114 5.0% Topical Gel BID for 6 weeks

Drug: ESR-114

Vehicle Gel

PLACEBO COMPARATOR

Placebo Topical Gel BID for 6 weeks

Other: Placebo

Interventions

ESR-114 DRUG

ESR-114 Topical Gel

ESR-114 1.5%; ESR-114 5.0%

Placebo OTHER

Placebo Topical Gel

Vehicle Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has a history of plaque psoriasis for at least 6 months.
• Subject has PGA of mild (2) or moderate (3) at Day 1.
• Subject has total LSS of ≥6 at Day 1.
• Subjects with plaque psoriasis-affected BSA to be treated of 1% to 15% at Screening and Day 1.

You may not qualify if:

• Subject has non-plaque psoriasis at Screening and Day 1.
• Subject has a history of skin disease or presence of skin condition that, in the opinion of the Investigator, would interfere with the study assessments at Screening and Day 1.
• Subject has used any topical therapy to treat psoriasis within 2 weeks prior to Day 1.

Sponsors & Collaborators

• Escalier Biosciences B.V.: lead
• Innovaderm Research Inc.: collaborator

Study Sites (10)

Study Site 19

Santa Monica, California, 90404, United States

Location

Study Site 16

Tampa, Florida, 33624, United States

Location

Study Site 17

Fridley, Minnesota, 55432, United States

Location

Study Site 14

Raleigh, North Carolina, 27612, United States

Location

Study Site 12

Austin, Texas, 78759, United States

Location

Study Site 11

College Station, Texas, 77845, United States

Location

Study Site 15

Houston, Texas, 77056, United States

Location

Study Site 18

San Antonio, Texas, 78213, United States

Location

Study Site 13

Peterborough, Ontario, K9J 5K2, Canada

Location

Study Site 10

Montreal, Quebec, H2K 4L5, Canada

Location

Study Officials

• Allison Luo, MD

  Escalier Biosciences B.V.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 15, 2018
• Study Start: August 9, 2018
• Primary Completion: June 5, 2019
• Study Completion: June 12, 2019
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

US (8); CA (2)